Badanie predyspozycji do raka u dzieci (CCPS) (CCPS)
The Childhood Cancer Predisposition Study (CCPS) is a multi-center, longitudinal, observational study that will collect clinical and biological data and specimens from children with a cancer predisposition syndromes (CPS) and their relatives.
The central hypothesis is that studying individuals at high risk for childhood cancer creates a unique opportunity for improving the understanding of carcinogenesis, tumor surveillance, early detection, and cancer prevention, which will collectively contribute to improving care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes (CPS).
Przegląd badań
Szczegółowy opis
The CCPS is designed as a multi-center, longitudinal, observational study that will collect clinical and biological data and specimens from children with a CPS and their relatives. The investigators plan to:
- Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies;
- Define the natural history of disease in children with CPS; and
- Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies.
The study will enroll approximately 350 Children and 700 Relatives per year. The investigators plan to collect demographic and diagnostic data at enrollment. Longitudinal follow-up will be performed at least annually.
The CCPS includes the establishment of a biorepository, with a hub and spoke structure, with a central repository at Emory University/Children's Healthcare of Atlanta for prospective collection of some tissues, linked to local biorepositories at participating institutions. Information about inventory of tumor specimens already banked locally will be available in the database, along with reference to existing genomic studies of the tumor, such that investigators may identify and request such tissue or data for specific studies, subject to approval of the CCPS Scientific Committee.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Christopher Porter, MD
- Numer telefonu: 4047274881
- E-mail: chris.porter@emory.edu
Lokalizacje studiów
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Ontario
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Toronto, Ontario, Kanada
- Rekrutacyjny
- Hospital for Sick Children
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Kontakt:
- Anita Villani, MD
- E-mail: anita.villani@sickkids.ca
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Rekrutacyjny
- Children's Healthcare of Atlanta (CHOA)
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Kontakt:
- Christopher Porter, MD
- Numer telefonu: 404-727-4881
- E-mail: chris.porter@emory.edu
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02215
- Rekrutacyjny
- Dana Farber Cancer Institute
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Kontakt:
- Lisa Diller, MD
- E-mail: lisa_diller@dfci.harvard.edu
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Rekrutacyjny
- Children's Hospital of Philadelphia
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Kontakt:
- Suzanne MacFarland, MD
- E-mail: macfarlands@chop.edu
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Tennessee
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Memphis, Tennessee, Stany Zjednoczone, 38105-3678
- Rekrutacyjny
- St. Jude Children's Research Hospital
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Kontakt:
- Kim Nichols, MD
- E-mail: kim.nichols@stjude.org
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Texas
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Houston, Texas, Stany Zjednoczone, 77030
- Rekrutacyjny
- Baylor College of Medicine
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Kontakt:
- Surya Rednam, MD
- E-mail: sprednam@texaschildrens.org
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Utah
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Salt Lake City, Utah, Stany Zjednoczone, 84113
- Rekrutacyjny
- Primary Children's Hospital
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Kontakt:
- Luke Maese, MD
- E-mail: luke.maese@hsci.utah.edu
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
The Primary Subjects of this study are children (age 0-21) with a CPS. Members of their Primary Family Unit will also be recruited for this study, including CPS-Affected Parents, Unaffected Parents and Siblings. Other adult family members (with documented or obligate CPS) are also eligible to enroll as Affected Family Members.
Opis
Inclusion Criteria:
Primary Subjects must meet all of the below criteria to be eligible for enrollment:
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Be less than 21 years of age at the time of enrollment
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Have a diagnosis of a specific CPS, whether they have had cancer or not
- Based on clinical laboratory testing demonstrating a Pathogenic or Likely Pathogenic germline variant and/or
- Based on well-established clinical diagnostic criteria and/or
- Based on high clinical suspicion of a specific CPS with clinical laboratory testing demonstrating a variant of uncertain significance (VUS)
Affected Parents must meet all of the following criteria to be eligible for enrollment:
- Be the biologic parent of a Primary Subject and
- Carry a diagnosis (or obligate diagnosis) of the familial CPS
Adult Affected Siblings must meet all of the following criteria to be eligible for enrollment:
- Be the biologic sibling of a Primary Subject and
- Carry a diagnosis (or obligate diagnosis) of the familial CPS
Unaffected Parents and Siblings must meet all of the following criteria to be eligible for enrollment
- Be the biologic parent or sibling of a Primary Subject and
- Not carry a diagnosis (or obligate diagnosis) of the familial CPS
Affected Family Members must meet all of the following criteria to be eligible for enrollment:
1. Carry a diagnosis of (or obligate diagnosis of) the familial CPS. Documentation is requested but not required.
More than one child from a Primary Family Unit may be a Primary Subject. An Unaffected Sibling may be reclassified as a Primary Subject if diagnosed with a CPS during childhood.
Exclusion Criteria:
- Individuals with a strong personal or family history of cancer without a genetic or clinical diagnosis of a specific CPS are not eligible for enrollment.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Primary Subjects
Children (age 0-21) with a cancer predisposition syndromes (CPS). |
This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition. |
|
Relatives of Children with CPS
Members of their Primary Family Unit will also be recruited for this study, including CPS-Affected Parents, Unaffected Parents and Siblings. Other adult family members (with documented or obligate CPS) are also eligible to enroll as Affected Family Members. |
This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Establish and maintain a framework for recruitment, participation, and surveillance of children with cancer predisposition syndromes (CPS) in clinical and translational research studies.
Ramy czasowe: Up to 10 years
|
This multicenter registry and biorepository will be developed with the purpose of studying individuals at high risk for childhood cancer to improve care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes (CPS). |
Up to 10 years
|
|
Define the natural history of disease in children with CPS.
Ramy czasowe: Up to 10 years
|
To define the natural history of disease in children with CPS. |
Up to 10 years
|
|
Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies.
Ramy czasowe: Up to 10 years
|
Evaluate the clinical impact and effectiveness of standard and emerging tumor surveillance strategies to improve care and outcomes for pediatric patients with cancer and those with cancer predisposition syndromes (CPS). |
Up to 10 years
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Christopher Porter, MD, Emory University
- Główny śledczy: Anita Villani, MD, The Hospital for Sick Children
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY00000109
- C3P-001 (Inny identyfikator: Consortium for Childhood Cancer Predisposition)
- 2020P002450 (Inny identyfikator: Emory IRB)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
De-identified, individual participant data reported in publications
Ramy czasowe udostępniania IPD
Beginning 3 months and ending 5 years following article publication.
Kryteria dostępu do udostępniania IPD
- Researchers who provide a methodologically sound proposal, to achieve the aims in the approved proposal
- Proposals should be directed to chris.porter@emory.edu. Requests will be reviewed by the study committee. Access to data will require a data access agreement.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- ICF
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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